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Guidance for Industry: On the Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for an Allergenic Extract or Allergen Patch Test, April, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008", "Supporting & Related Material", "REF-Reference (internal unless indicated)", "2008-12-04T05:00:00Z", 2008, 12, null, null, "2008-12-23T01:30:01Z", null, 0, 0, "09000064807caf64"], ["FDA-1999-D-0128-0014", "FDA", "FDA-1999-D-0128", "Reference 6 - CBER Refusal to File Guidance for Product License Applications (PLAs) & Establishment License Applications (ELAs), July 12, 1993 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008", "Supporting & Related Material", "REF-Reference (internal unless indicated)", "2008-12-04T05:00:00Z", 2008, 12, null, null, "2008-12-23T01:30:02Z", null, 0, 0, "09000064807caf54"], ["FDA-1999-D-0128-0018", "FDA", "FDA-1999-D-0128", "Reference 10 - 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